FDA Rejects Canagliflozin/Metformin Combo for Now

Miriam E. Tucker

January 09, 2014

(Corrected January 15, 2014) The US Food and Drug Administration (FDA) has informed Janssen Research & Development that it needs more information before the fixed-dose canagliflozin/metformin combination can be approved for the treatment of type 2 diabetes.

The company announced last month that it had received a "complete response letter" from the US agency asking for more data to support comparability of the proposed dosing of the fixed-dose combination with that of once-daily canagliflozin (Invokana).

"Janssen believes it can supply this information based on available clinical data from the comprehensive phase 3 clinical development program for canagliflozin," the company said in a statement.

Approved by the FDA as a single agent in March 2013, canagliflozin is an oral inhibitor of the sodium glucose cotransporter 2 (SGLT2), blocking resorption of glucose by the kidney and thereby promoting glycosuria with a consequent lowering of both blood glucose and body weight. Metformin is a first-line oral medication that reduces hepatic glucose production and is the most commonly used therapeutic in type 2 diabetes.

According to the company statement, "If approved, the canagliflozin and metformin fixed-dose combination could provide convenience for patients who may benefit from the 2 diabetes medications in 1 tablet."

The FDA has just approved a second SGLT2 inhibitor, dapagliflozin(Farxiga, AstraZeneca/Bristol-Myers Squibb) at its second attempt to gain US clearance.

The combination of dapagliflozin/metformin (Xigduo , AstraZeneca/Bristol-Myers Squibb) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for the treatment of type 2 diabetes in the European Union in November 2013, and subsequent approval is usually a formality within a couple of months.

Canagliflozin was approved in the European Union in November, where it is also marketed as Invokana; it is also available in Australia.

An earlier version of this story incorrectly stated that canagliflozin was not approved in the European Union.

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